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Warner Chilcott Laboratories, Rockaway, N.J., (800) 521-8813, has been granted FDA permission to market Femtrace (estradiol acetate) tablets for oral administration. The drug, approved for the relief of the vasomotor symptoms associated with menopause, will be available in three strengths: 0.45, 0.9, and 1.8 mg per tablet.
From the specialty products division of Schwarz Pharma, Milwaukee, (800) 558-5114, comes a proprietary combination formulation. Parcopa (carbidopa-levodopa orally disintegrating tablets) utilizes Schwarz's RapiTab technology, which formulates medicines into tablets that dissolve rapidly in the mouth. They can be swallowed with or without water. RapiTab tablets are convenient for patients to administer, especially when they face dosing obstacles (such as the inability to swallow a tablet or capsule) or when water is not readily available. The drug was designed to provide patients suffering from Parkinson's disease improved access to their medication. Parcopa is available in the same strengths and has the same dosage schedule as conventional Sinemet, from Merck & Co. The combination drug helps reduce the harmful side effects caused by long-term levodopa use.
Doak Dermatologics, Fairfield, N.J., (800) 929-9300, has added Rosula NS Medicated Pads to its family of topical treatments. The new medicated pad combines sodium sulfacetamide (for antibacterial activity) with urea (for moisturizing, keratolytic, and antimicrobial properties). Doak claims the product is more than two times larger than other prescription medicated pads, providing for a broader treatment area.
Approved earlier and newly launched is Factive (gemifloxacin mesylate), from Oscient Pharmaceuticals, Waltham, Mass., (781) 398-2300. The fluoroquinolone antibiotic is available in 320-mg tablets, indicated for the treatment of acute bacterial exacerbations of chronic bronchitis and mild to moderate community-acquired pneumonia. The once-daily therapy requires no dosing adjustment in the elderly, in individuals with liver impairment, or persons with mild to moderate renal impairment.
PrimaCare ONE, a prescription nutritional product, provides prenatal essential fatty acids for mothers and babies, as well as ongoing nutritional support for women during their childbearing years. Ther-Rx Corp., a branded pharmaceutical subsidiary of KV Pharmaceutical Co., St. Louis, (314) 645-6600, is launching the product.
Alliant Pharmaceuticals, Alpharetta, Ga., (770) 817-4500, a pediatric specialty pharmaceutical company, has received approval for Methylin Chewable Tablets and Methylin Oral Solution for the treatment of attention deficit/hyperactivity disorder. According to the company, these are the first methylphenidate hydrochloride products to gain FDA acceptance in these formulations. The tablets are available in 2.5-, 5-, and 10-mg strengths; the oral solution provides 5 mg/5 mL and 10 mg/5 mL dosing.
Geodon (ziprasidone HCl), already approved for treating schizophrenia, has a new indication: treatment of acute bipolar mania, including manic and mixed episodes. The atypical antipsychotic, a product of Pfizer Inc., New York City, (212) 733-2323, will not cause significant weight gain, as do other bipolar medications, according to the company.
The FDA has approved Cymbalta (duloxetine HCl) capsules, from Eli Lilly, Indianapolis, (800) 545-5979, for the management of the pain associated with diabetic peripheral neuropathy. According to the company, this is the first drug specifically approved for this indication. Cymbalta, a reuptake inhibitor of serotonin and norepinephrine, was approved earlier as a treatment for major depressive disorder.
Digoxin, which was cleared earlier for strengthening the heart's contractions to slow the heartbeat, has been approved in 0.05 mg/mL Digoxin elixir USP, for treatment of heart failure and atrial fibrillation. The manufacturer is Roxane Laboratories, Columbus, Ohio, (614) 272-4774.
A new indication has been granted for Saizen (somatropin [rDNA origin] for injection), a product of Serono Inc., Rockland, Mass., (888) 275-7376. Previously approved for long-term treatment of children with growth failure, the product can now be used for long-term growth hormone replacement in adults with confirmed growth hormone deficiency of either adult or childhood onset.
Schering-Plough, Kenilworth, N.J., (908) 298-4000, is marketing Clarinex (desloratadine) Syrup with new indications: the relief of symptoms associated with seasonal allergic rhinitis (outdoor allergies) in children two years of age and older and symptomatic relief of perennial allergic rhinitis (indoor allergies) and chronic idiopathic urticaria (hives) in children as young as six months of age.
Schering-Plough's Nasonex (mometasone furoate monohydrate) is now available in a newly approved formulation. Scent-free Nasonex, a once-daily nasal inhaled steroid, is indicated to help prevent most seasonal nasal allergy symptoms in adults and children 12 years of age and older and to treat nasal allergy symptoms in patients as young as two years of age.
Unimed Pharmaceuticals, a subsidiary of Solvay Pharmaceuticals, Marietta, Ga., (770) 578-9000, is now offering AndroGel (testosterone gel) 1% in a non-aerosol, metered-dose pump, designed to deliver 1.25 gm of gel per pump depression. The Schedule III testosterone replacement gel is still available in 2.5- and 5-gm packets of the clear topical gel, indicated for treating men with hypogonadism.
Final marketing approval has been granted to Impax Laboratories, Hayward, Calif., (510) 476-2000, for metformin HCl extended-release tablets, in 500-mg strength. The generic alternative to Bristol-Myers Squibb's Glucophage XR, 500 mg, is indicated for improving glycemic control in patients with Type 2 diabetes.
Omeprazole delayed-release capsules, in 20-mg strength, a product of Impax Laboratories, is being launched by TEVA Pharmaceuticals, North Wales, Pa. (888) TEVA USA. A generic version of AstraZeneca's Prilosec, the product is indicated for the treatment of duodenal/gastric ulcers and gastroesophageal reflux disease.
Mylan Laboratories, Pittsburgh, (724) 514-1800, has received final approval for metoprolol tartrate and hydrochlorothiazide tablets, 50/25 mg, 100/25 mg, and 100/50 mg. The combination product, indicated for the treatment of hypertension, is a generic version of Lopressor HCT tablets, from Novartis ... Mylan has also received tentative FDA approval for cetirizine HCl tablets, 5 mg and 10 mg, and for sertraline HCl tablets, 25 mg (base), 50 mg (base), and 100 mg (base). Cetirizine HCl is a generic version of Pfizer's antihistamine Zyrtec; sertraline HCl is a generic version of Pfizer's antidepressant Zoloft.
Eurand, based in Milan, Italy, has been given final FDA approval for potassium chloride 20-mEq tablets. The potassium supplement, used in the treatment of hypokalemia, digitalis intoxication, and hypokalemic familial periodic paralysis, provides a generic alternative to Key Pharmaceutical's K-Dur 20 tablets. Eurand, with a U.S. office in Vandalia, Ohio, (937) 898-9669, will license the product in the United States to a marketing partner.
Dextroamphetamine sulfate extended-release capsules, 5 mg CII, 10 mg CII, and 15 mg CII, have been approved for Able Laboratories, South Plainfield, N.J., (908) 754-2253. The approval provides a generic alternative to GlaxoSmithKline's Dexedrine Spansule sustained-release capsules in the same strengths. The drug is used to treat narcolepsy and attention deficit/hyperactivity disorder.
The FDA has approved allopurinol sodium for injection for the management of patients with leukemia, lymphoma, and solid-tumor malignancies who are receiving cancer therapy. The maker is Bedford Laboratories, Bedford, Ohio, (440) 232-3320. The drug provides a generic alternative to Aloprim, from Nabi Pharmaceuticals.
For Barr Laboratories, Woodcliff Lake, N.J., (800) 222-0190, the FDA has approved a generic version of GlaxoSmithKline's Zofran ODT (ondansetron) Orally Disintegrating Tablets, 4 mg and 8 mg. Ondansetron orally disintegrating tablets, in the same strengths, are indicated for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy and certain radiotherapies and for the prevention of postoperative nausea and/or vomiting.
Ranbaxy Pharmaceuticals, Princeton, N.J., (609) 720-9200, has tentative approval for two new drugs. Gabapentin capsules, in 100-, 300-, and 400-mg strengths, provide a generic alternative to Pfizer's Neurontin. They are indicated for the management of postherpetic neuralgia in adults, as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy, and as adjunctive therapy in the treatment of partial seizures in pediatric patients three to 12 years of age. Fosinopril sodium and hydrochlorothiazide tablets, 10 mg/12.5 mg and 20 mg/12.5 mg, are indicated for the treatment of hypertension but not for initial therapy. The branded drug is Bristol-Myers Squibb's Monopril-HCT, an ACE inhibitor.